Republic of the Philippines Department of Health Food and Drug Administration Importation of Unregistered Drug Products Center for Drug Regulation and Research Food and Drug Administration
Presentation Outline I. Food and Drug Administration II. Use of Unregistered Products III.Issues for Discussion 5 May 2015 2
Objective Discuss and solicit comments from stakeholders on issues arising from the importation of unregistered drug products
Republic of the Philippines Department of Health Food and Drug Administration Food and Drug Administration
To ensure the safety, efficacy, purity, and quality of products we regulate through effective implementation of the national regulatory framework consistent with international best practice MISSION 5
To be an internationally recognized center of regulatory excellence safeguarding the health of the Filipinos VISION 6
QUALITY POLICY Our highest commitment is to ensure the safety, efficacy and quality of health products. Toward this end, we commit to establish science- based standards as basis for regulatory policies, to continually improve and maintain our competencies in relation to our regulatory function, and to deliver quality public service with integrity. 7
Regulatory Framework Elements 1. Licensing/Accreditation of establishments GMP, GDP, GSP, GCP, and GLP • 2. Pre-marketing assessment Quality, safety, and efficacy (for innovative medicines) • Quality+interchangeability (for generics) • 3. Post-marketing surveillance Safety (benefit/risk balance) • Quality (quality testing and compliance monitoring) • 4. Communication 8
1. Pharmacovigilance • Safety monitoring of drugs on the market for unexpected health risks and informing the public of risks posed by specific drugs and other health products; 2. Monitoring, collecting, sampling and testing of drugs 3. Audits and inspection of manufacturers/ distributors/ retail outlets 4. Advertisements and claims monitoring 5. Consumer reporting of ADR 6. Product recall / Administrative sanctions Post-Marketing Surveillance 9
Summary.. • Regulatory safeguards are in place to protect the public • Licensing of establishments, registration of products, and post licensing and post marketing surveillance
Republic of the Philippines Department of Health Food and Drug Administration Use of Unregistered Products
k)a, Sec. 1 General Provision, Article I, Book II IRR of RA 9711
• FDA recognizes the need for drugs and devices product/preparation which are not registered or are in the process of registration in the Philippines by patients who are terminally or seriously ill. • Access to these products for these patients is morally, socially and ethically justified when there is no existing superior alternative therapy that can likely cure or adequately control their conditions. 5 May 2015 13
Administrative Order No. 4 s. 1992 5 May 2015 14
AO No. 4 s. 1992 Compassionate Special Permit for Restricted Use of Unregistered Drug and Devices Product (CSP) • a special permit signed by the FDA Director granting a Specialized Institution (SI) and Specialty Society (SS) the privilege to avail of an unregistered drug and device product through a certain licensed establishment for certain kind/type of patients, specific volume and period. 5 May 2015 15
AO No. 4 s. 1992 • For patients suffering from the following conditions: 1. A cquired Immune Deficiency Syndrome (AIDS) 2. Cancer 3. Life-threatening conditions 5 May 2015 16
Application shall include: • estimated volume needed • the licensed drug/ device establishment through which the unregistered drug may be procured • identify the names and address of the specialists qualified and authorized to use the product AO No. 4 s. 1992 5 May 2015 17
Top Requested Drugs Quantity requested per year Frequency of request Drug 2013 2014 Total 2013 2014 Total 7600 37170 44770 13 23 36 Colistimethate Na 1 M Unit vial 10333 16382 26715 12 18 30 Dipyridamole 10mg/2ml ampoule 14990 9319 24309 8 20 28 Glyceryl trinitrate 10mg/10ml amp 11475 6691 18166 13 22 35 Protamine sulfate 50mg/5ml vial 4425 6895 11320 10 14 24 Vasopressin 20 units/ml vial 3963 5605 9568 15 30 45 Adenosine 6mg/2ml vial 2700 4985 7685 9 17 26 Phenylephrine 1% 10mg/1ml vial 1495 2908 4403 8 19 27 Papaverine HCl 30mg/ml, in 2ml vial 1405 2958 4363 10 21 31 Esmolol HCl 10mg/ml, in 10 ml vial 2302 2057 4359 10 14 24 Milrinone lactate 10mg vial 408 850 1258 11 20 31 Dantrolene sodium 20mg/65mL vial
Top Requested Drugs Quantity requested per year Frequency of request Drug 2013 2014 Total 2013 2014 Total 10400 13030 23430 2 2 4 Sotalol 80mg tablet 4400 14500 18900 1 2 3 Propafenone 150mg tablet 7220 7800 15020 4 4 8 Liothyronine (Cynomel) 25mcg tablet Co-trimoxazole (Trimethoprim 16 mg/ml 1450 9112 10562 3 8 11 + Sulfamethoxazole 80 mg/ml) [Bactrim] Solution for injection, in 5ml vial 3100 5800 8900 2 4 6 Fludrocortisone 0.1mg tablet 1700 3400 5100 2 2 4 Provocholine nebulization kit 288 475 763 2 2 4 Provocholine 100mg/vial
Top Requesting Hospitals No. of applications per year Hospitals 2014 Total 2013 6 12 18 St. Luke's Medical Center – Global City 8 8 16 St. Luke's Medical Center – Quezon City 8 7 15 Cardinal Santos Medical Center 5 7 12 The Medical City 7 3 10 Philippine General Hospital 3 6 9 Makati Medical Center 2 6 8 University of Santo Tomas Hospital 2 5 7 Asian Hospital and Medical Center 2 5 7 Manila Doctors Hospital 2 2 4 Philippine Heart Center
Republic of the Philippines Department of Health Food and Drug Administration Issues for Discussion
Issues for Discussion • Misalignment with AO 4 • Concerns from Hospital Group • List of Products
Misalignment with AO 4 • Regular request (from 2 to 12 times a year) for permit to import of unregistered to be used for critical care, strictly for their own use • Quantity is considered to be substantial • No specific patients identified
Concerns from Hospital Group • 13 April 2015 – representatives from PHA and PSHP • Some of the concerns: – Hospitals acknowledge the risks – waiver – No choice – no MAH/importer is willing to register due to “low volume” = not profitable – Some drugs are included in the PNDF but not available in the market
List of Products Drug Company* WEST WARD PHARM CORP; ECLAT Phenylephrine 1% 10mg/1ml vial PHARMS LLC; Nitroprusside (Nitropress) 50mg/2ml vial HOSPIRA Dantrolene sodium (Revonto) 20mg/65mL US WORLDMEDS vial PAR STERILE PRODUCTS BEDFORD Dipyridamole (Persantin) 10mg/2ml FRESENIUS KABI USA ampoule HIKMA MAPLE Protamine sulfate 10mg/ml, in 5ml vial FRESENIUS KABI USA Thrombin 5000 units/5ml vial PapaverineHCl30mg/ml, in 2ml vial AMERICAN REGENT, INC. Vasopressin (Pitressin) 20 units/ml vial PAR STERILE PRODUCTS EMCURE PHARMS LTD; FRESENIUS KABI USA; Colistimethate sodium (Colomycin) 1 Million PADDOCK LLC; Unit vial AGENT PHARMS; X GEN PHARMS; PAR STERILE PRODUCTS
List of Products Drug Company* BEDFORD; FRESENIUS KABI USA; Milrinone lactate 10mg/10ml vial GLAND PHARMA LTD HOSPIRA INC Ferric subsulfate (Astringyn) topical solution Cooper Surgical AMDIPHARM MERCURY COMPANY LIMITED; Adenosine (Adenocor) 6mg/2ml vial FOCUS PHARMACEUTICALS LTD; WOCKHARDT UK LTD BAXTER HEALTHCARE; EUROHLTH INTL SAR; EsmololHCl (Brevibloc) 10mg/ml, in 10 ml FRESENIUS KABI USA; vial LUITPOLD; MYLAN INSTITUTIONAL ARCHIMEDES PHARMA UK LTD Thiopental sodium 500mg Powder for Injection Solution, in Vial Ferric subsulfate (Monsel’s) 8 ml Solution Clique Hemostasis Products
List of Products Drug Company* SAGENT PHARMS; AKORN; Lidocaine HCl 2% Jelly USP, 30ml tube INTL MEDICATION; WATSON LABS INC; OAK PHARMS Streptokinase (Streptase) 1.5 Million units, vial BEACON PHARMACEUTICALS; CSL BERHING UK LIMITED LUITPOLD; Aminocaproic acid 250mg/ml, 20ml vial HOSPIRA International Medication Systems (UK) Calcium chloride 100mg/ml, 10ml vial Novartis Pharmaceuticals Cyclosporine (Sandimmune) 250mg/5ml ampoule
List of Products Drug Company* HOSPIRA; AGILA SPECLTS; BEDFORD; Etomidate (Amidate) 2mg/ml, 10ml vial EMCURE PHARMS LTD; LUITPOLD; PAR STERILE PRODUCTS; ZYDUS PHARMS USA INC AKORN INC; EUROHLTH INTL SARL; Labetalol HCl injection 100mg/20ml vial GLAND PHARMA LTD; HOSPIRA UCB INC; Metolazone 5mg tablet SANDOZ; MYLAN GABAUER COMPANY Pentafluoropropanetetrafluoroethane (Gebauer'spain Ease) 3.5 Oz Medium Stream Spray
List of Products Drug Company* ASPEN Estriol (Ovestin) Vaginal Cream 1mg/g, 15g tube ABBOTT Verapamil HCl 2.5mg/ml ampoule HOSPIRA ATON PHARMA, INC. Trientinedihydrochloride (Syprine) 300mg capsule UCB PHARMA LIMITED Isosorbidedinitrate (Isoket) 0.1% 1mg/ml ampoule E.R. SQUIBB & SONS LIMITED Fludrocortisone 0.1mg tablet COVIS PHARMA SARL; UPSHER SMITH; APOTEX; EPIC PHARMA INC; Sotalol 120mg tablet IMPAX PHARMS; MYLAN; SANDOZ; TEVA; VINTAGE
List of Products Drug Company* COVIS PHARMA SARL; UPSHER SMITH; APOTEX INC; EPIC PHARMA INC; Sotalol 80mg tablet IMPAX PHARMS; MYLAN; SANDOZ; TEVA; VINTAGE AKORN INC; BEDFORD; Diltiazem 5mg/ml, 10ml vial HIKMA FARMACEUTICA; HIKMA MAPLE;
Recommend
More recommend
